N/A
N=168
Risk of Nephrogenic Systemic Fibrosis (NSF) in Patients With Moderate Renal Insufficiency After the Administration of Magnevist
Fibrosis · Kidney Failure · Renal Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT00744939 ↗Enrolled (actual)
168
Serious AEs
0.7%
Results posted
Sep 2014
Primary outcome: Primary: Number of Participants Who Developed Nephrogenic Systemic Fibrosis (NSF), Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Full Analysis Set — 0; 0; 0; 0 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Gadopentetate dimeglumine (Magnevist, BAY86-4882) (Drug)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Developed Nephrogenic Systemic Fibrosis (NSF), Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Full Analysis Set |
0; 0; 0; 0 | — |
| PRIMARY Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-full Analysis Set |
— | — |
| PRIMARY Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-cohort Analysis and Per Protocol Set |
0; 0 | — |
| PRIMARY Number of Participants Who Developed NSF, Based on Diagnostically Specific Clinical and Histopathological Information-per Protocol Set |
— | — |
| SECONDARY Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-cohort Analysis and Full Analysis Set |
0; 0; 0; 0 | — |
| SECONDARY Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-full Analysis Set |
— | — |
| SECONDARY Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-cohort Analysis and Per Protocol Set |
0; 0 | — |
| SECONDARY Total Number of Participants With Clinicopathological Correlation of 'NSF' or 'Consistent With NSF' and Subjects Without Biopsy Developing Clinical Signs Consistent With NSF-per Protocol Set |
— | — |
| SECONDARY Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-cohort Analysis and Full Analysis Set |
0; 0; 0; 0; 0; 3 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-full Analysis Set |
0; 15 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-cohort Analysis and Per Protocol Set |
0; 0; 7; 0 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) Reported in Association With the Administration of Magnevist-per Protocol Set |
0; 7 | — |
Summary
Assess potential risk for NSF in subjects with renal impairment (moderate) post magnevist injection. Subjects will be screened within 48 hours of previously scheduled MRI, those meeting the enrollment criteria will be enrolled prior to MRI and followed for 2 years post MRI with visits occuring at 1yr and 2 yr timepoints, in addition follow-up phone calls conducted at 1, 3, 6 and 18 months to assess for skin changes suggestive of NSF.
Eligibility Criteria
Inclusion Criteria
- Patients must have moderate (eGFR 30-59 ml/min/1.73 m^2) renal impairment and be scheduled for a contrast enhanced MRI with Magnevist Injection at the recommended dose of 0.1 mmol/kg.
Exclusion Criteria
- Gadolinium Based Contrast Agent (other then Magnevist) enhanced MRI within 12 months prior to administration of Magnevist
- History of NSF
- Clinically unstable or age <2 yrs
Data sourced from ClinicalTrials.gov (NCT00744939). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.